Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Overview

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Full Title of Study: “Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

Interventions

  • Drug: Alprazolam tablet
    • 1 mg single dose of alprazolam conventional tablet
  • Drug: Alprazolam sublingual
    • 1 mg single dose of alprazolam sublingual tablet

Arms, Groups and Cohorts

  • Active Comparator: Alprazolam conventional tablet
    • Alprazolam conventional tablet
  • Experimental: Alprazolam sublingual tablet
    • Alprazolam sublingual tablet

Clinical Trial Outcome Measures

Primary Measures

  • Area under the curve (AUC) from time zero to last measurable time of alprazolam
    • Time Frame: 72 hours
  • Peak concentration of alprazolam
    • Time Frame: 72 hours

Secondary Measures

  • Area under the curve from time zero to infinity
    • Time Frame: 72 hours
  • AUC% extrapolated
    • Time Frame: 72 hours
  • Time of Cmax
    • Time Frame: 72 hours
  • half-life of alprazolam
    • Time Frame: 72 hours
  • Clinically significant safety laboratory tests
    • Time Frame: Screening, Day 0, Day 4
  • Clincally significant vital signs
    • Time Frame: Screening, Day 4
  • Clinically significant adverse events
    • Time Frame: 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. – Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. – Signed informed consent. Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities – Positive drug screen, excessive alcohol and tobacco use

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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